Safety; Intended Use; Indication; Signs And Symbols - Ivoclar Vivadent Bluephase N MC Instructions For Use Manual

2. Safety

2.1. Intended use

Bluephase N MC is an LED polymerization light that pro-
duces energy-rich blue light. It is used for the polymeriza-
tion of light-curing dental materials immediately at the
dental unit. The intended use also includes the observa-
tion of the notes and regulations in these Instructions for
Use.

2.2. Indication

Bluephase N MC is suitable for the polymerization of all
light-curing dental materials curing in the wavelength
range of 430–490 nm. These materials include restora-
tives, bonding agents/adhesives, bases, liners, fissure
sealants, temporaries, as well as luting materials for
brackets and indirect restorations, such as ceramic inlays.

2.3. Signs and symbols

Contraindication

Symbols on the curing light
Double insulation
(device complies with safety class II)
Protection against electrical shock
(BF type apparatus)
Observe Instructions for Use
Observe Instructions for Use
Caution
The appliance must not be disposed of as
urban waste. Information regarding the
disposal of appliance can be found on the
respective national Ivoclar Vivadent home-
page.
Alternating current
Direct current
4

2.4. Safety notes

Bluephase N MC is an electronic device and a medical
product which is subject to IEC 60601-1 (EN 60601-1)
and EMC directives, as well as the 93/42/EEC Medical
Device Di-rective. The appliance complies with the rele-
vant EU regulations and is classified as an LED Class 2
product.
NRTL (Nationally Recognized
Testing Laboratory)
The curing light has been shipped from the manufacturer
in a safe and technically sound condition. In order to
maintain this condition and to ensure risk-free operation,
the notes in these Instructions for Use have to be
observed. To prevent damage to equipment and risks for
patients, users and third parties, the following safety
instructions have to be observed.
2.5. Contraindication
Materials whose polymerization range is
activated outside the wavelength range of
430–490 nm. If you are not sure about certain
materials, please ask the manufacturer of the
corresponding product.
Use without light probe.
Do not use the appliance near flammable or
combustible substances.
Portable and mobile high-frequency
communication devices may interfere with
medical equipment. The use of mobile phones
during operation is not allowed.